Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro d
FDA device recall Z-2324-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Trek Diagnostic Systems
- Reason for recall
- Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.
- Action taken
- On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JTZ
- Quantity affected
- 31 boxes/10/11 ml tubes
- Distribution
- Nationwide Distribution -- PA, VA & WA.
- Date initiated
- 2009-06-04
- Date posted
- 2009-09-30
- Date terminated
- 2010-02-26
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENSITITRE SUSCEPTIBILITY PLATES (K860753) | Gibco Laboratories Life Technologies, Inc. | 1986-05-06 |